All subjects will receive the vaccine subcutaneously every 3 weeks x 3 and then every 3 months for 3 years. The rationale for using Poly-ICLC as an adjuvant are two ongoing trials at University of Pittsburgh Cancer Institute (UPCI) of the MUC1 100mer peptide vaccine - one as a therapeutic vaccine in subjects with metastatic castrate resistant prostate cancer and the other in subjects with advanced colonic adenomas at risk for developing colon cancer. The same formulation, MUC1 100mer peptide admixed with Poly-ICLC, is used in both trials. There has been no toxicity observed and the vaccine is highly immunogenic in early disease. In the proposed NSCLC trial the anti-MUC1 immune response will be thoroughly characterized.

To characterize the change in the balance between immunocompetence (response of T cells to polyclonal stimulation) versus immunosuppression at different stages of disease {check for increased numbers of regulatory T cells (Treg) and Myeloid-Derived Suppressor Cells (MDSC)}

Resection or radiotherapy without adjuvant chemotherapy followed by 3 cycles of vaccination.

Biological: Vaccine + PolyICLC

The vaccine will consist of 100 micrograms of MUC1 100mer peptide dissolved in 50 micro-liters of sterile saline, admixed with 500 micrograms of Hiltonol® in 250 microliters volume, for a total injection volume of 300 microliters.

Experimental: Stage IB/II/IIIA

Resection and adjuvant chemotherapy followed by 3 cycles of vaccination.

Biological: Vaccine + PolyICLC

The vaccine will consist of 100 micrograms of MUC1 100mer peptide dissolved in 50 micro-liters of sterile saline, admixed with 500 micrograms of Hiltonol® in 250 microliters volume, for a total injection volume of 300 microliters.

Experimental: Stage IIIA or IIIB

Concomitant chemo-irradiation followed by 3 cycles of vaccination.

Biological: Vaccine + PolyICLC

The vaccine will consist of 100 micrograms of MUC1 100mer peptide dissolved in 50 micro-liters of sterile saline, admixed with 500 micrograms of Hiltonol® in 250 microliters volume, for a total injection volume of 300 microliters.

The effects of a MUC1vaccine on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, men and women of childbearing potential must be willing to use effective contraception (hormonal barrier method of birth control; abstinence) while on study treatment and for at least 3 months thereafter. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

Exclusion Criteria:

Subjects may not be receiving any other investigational agents

Positive ANA lab result

Known Hepatitis B on immunomodulators (i.e. interferon)

Known Hepatitis C on immunomodulators (i.e. interferon)

No prior vaccine therapy

Patients may not be receiving any steroids or other anti-immune therapy at the time of registration.

Subjects must not be more than 6 weeks from standard of care treatment for their particular stage of disease

Subjects must not have post-obstructive pneumonia or other serious infection at the time of registration or other serious underlying medical condition that would impair the ability of the subjects to receive protocol treatment

Prior resection of lung cancer is allowed, if at least five years have elapsed between previous resection and registration

Pregnant women are excluded from this study. Women of childbearing potential must have a negative pregnancy test

Subjects with immune deficiency are not expected to respond to the vaccine. Therefore, known HIV-positive patients are excluded from the study

Subjects with a history of known autoimmune disease are excluded from this study

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01720836